Cleared Traditional

K881222 - JOHNSON & JOHNSON FLUFF SPONGE

K881222 · Johnson & Johnson Professionals, Inc. · General & Plastic Surgery device
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Mar 1988
Decision
6d
Days
-
Risk

K881222 is an FDA 510(k) clearance for the JOHNSON & JOHNSON FLUFF SPONGE. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Johnson & Johnson Professionals, Inc. (Raynham, US). The FDA issued a Cleared decision on March 28, 1988 after a review of 6 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Johnson & Johnson Professionals, Inc. devices

Submission Details

510(k) Number K881222 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1988
Decision Date March 28, 1988
Days to Decision 6 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 115d · This submission: 6d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFQ Gauze/sponge, Internal
Device Class -

Regulatory Peers - EFQ Gauze/sponge, Internal

All 43
Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K881222.
NON-ABSORB GAUZE SURG SPONGE & WOUND DRESS/EXT USE
K891460 · Smith & Nephew United, Inc. · Apr 1989
ABSORBENT GAUZE ROLL
K885143 · Smith & Nephew, Inc. · Feb 1989
GAUZE SWABS, NON-STERILE
K885142 · Smith & Nephew, Inc. · Jan 1989
ENVINET(TM)
K874551 · Marion Laboratories, Inc. · Jan 1988
PHARMANET (TM)
K872572 · Pharmacia, Inc. · Jan 1988
AQUATULLE FINE MESH NON-ADHERING DRESSING
K872759 · Smith & Nephew, Inc. · Sep 1987